This product is a preparation containing vitamins, minerals, and trace elements.
Each film-coated tablet contains: Calcium 125 mg, Magnesium (as Magnesium oxide heavy) 100 mg, Ascorbic acid (Vitamin C) 85 mg, Vitamin E (as dl-α-Tocopherol acetate concentrate) 44.70 mg, Iron (as Ferrous bisglycinate) 27 mg, Nicotinamide 18 mg, Zinc 11 mg, Calcium pantothenate (Vitamin B5) 6.52 mg, Pyridoxine HCl (Vitamin B6) 2.31 mg, Manganese (Manganese Sulfate Monohydrate) 2 mg, Thiamine nitrate (Vitamin B1) 1.73 mg, Riboflavin (Vitamin B2) 1.40 mg, Copper (as Copper sulfate anhydrous) 1 mg, Biotin 0.03 mg, Cholecalciferol (Vitamin D3) 1000 IU, Vitamin B9 (as L-methylfolate, calcium) 451 mcg, Folic acid (Vitamin B9) 400 mcg, Iodine (as Potassium Iodide) 220 mcg, Selenium (as Sodium selenite) 50 mcg, Cyanocobalamin (Vitamin B12) 2.60 mcg.
The product is a white to slightly greyish oval and biconvex film-coated tablet.
Multivitamins and Minerals (Elevit Pre-conception) is indicated in adult women and adolescent girls who are planning a pregnancy or who are pregnant.
Multivitamins and Minerals (Elevit Pre-conception) preparation for the prevention and treatment of vitamin and mineral deficiencies in preparation for pregnancy, and during pregnancy.
Reduction of the risk of first occurrence neural tube defects and other congenital abnormalities when taking the product for the recommended duration starting at least one month before conception.
Prevention and treatment of iron and folate deficiency anemia during pregnancy.
One tablet daily to be taken as a whole with a glass of water preferably with a meal. In case of morning sickness, it is recommended that the tablet is taken at noon or in the evening. The recommended duration of administration for adolescent girls and adult women is at least one month before conception (when planning a pregnancy) and throughout the pregnancy.
Missed dose: If the patient missed a dose, skip the missed tablet and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.
Signs and Symptoms of Overdose: There is no evidence that this product can lead to an overdose when used as recommended. Most, if not all reports concerning overdoses of vitamins and minerals are associated with concomitant intake of high dosed single and/or multivitamin preparations. Acute or long-term overdose can cause hypervitaminosis A and D and hypercalcaemia as well as iron and copper toxicity.
Uncharacteristic initial symptoms, such as abrupt onset of headache, confusion, and gastrointestinal disturbances such as constipation, diarrhea, nausea, and vomiting might be indicative for an acute overdose.
If such symptoms occur, treatment must be stopped and a health care professional consulted.
What to do when the patient has taken more than the recommended dosage: There is no specific antidote however patients should still consult their physician.
Known hypersensitivity to any component in the product; Severe impaired renal function; Existing hypervitaminosis D; Hypercalcaemia; Severe hypercalciuria; Iron and/or copper metabolism disorders.
The recommended dosage must not be exceeded. Very high doses of some ingredients, in particular vitamin D, iron and copper, can be harmful to health. (See Overdosage.)
Patients receiving other single vitamins or multivitamin preparations, any other medication or those under medical care should consult a health care professional before taking this product. (See Interactions.)
This preparation must be taken with particular caution together with other products, including supplements and/or fortified foods/drinks containing Vitamin D, since large daily doses may cause hypervitaminosis D. (See Overdosage.)
As calcium, ascorbic acid and Vitamin D may have an effect on stone formation, patients with nephrolithiasis or urolithiasis should use caution when using vitamin supplements.
When should the patient consult a doctor: If symptoms of overdosage occur, the product should be stopped and a health care professional consulted.
Pregnancy: Chronic overdose of vitamin D might be harmful to the fetus.
An overdose of vitamin D must be avoided as permanent hypercalcaemia can lead to physical and mental retardation, supravalvular, aortic stenosis and retinopathy in the child.
In animals, overdoses of vitamin D during pregnancy have been shown to have teratogenic effects. There is no evidence that vitamin D at the recommended dose is teratogenic in humans.
During pregnancy and lactation the daily intake should not exceed 2500 mg calcium, and 4000 IU (100 μg) vitamin D, Elevit Pre-conception does contain 125 mg Calcium and 1000 IU Vitamin D.
Intake of food rich in vitamin D and intake of fortified foods and drinks, which may contain high levels of this vitamins, must be taken into account.
General remark: Adequate maternal micronutrient status is especially critical during pregnancy and the requirements for most micronutrients are higher in these periods. A complete multivitamin product containing folic acid, vitamin D, as well as of the other ingredients can thus be used during pregnancy and lactation to ensure sufficient micronutrient intakes.
Lactation: Permanent overdose of vitamin D might be harmful to the neonate.
The vitamins and minerals in this preparation are excreted into breast milk. This must be taken into consideration if the infant is receiving any respective supplements.
Fertility: There are no data on the effect of the medicinal product on fertility.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Gastrointestinal Disorders: Gastrointestinal and abdominal pain, constipation, diarrhea, nausea and vomiting may occur.
Immune system disorders: In isolated cases this product may cause allergic or anaphylactic reaction. Symptoms may include hives, facial swelling, wheezing, skin reddening, rash, blisters, and shock. If an allergic reaction occurs, treatment must be stopped and a health care professional consulted.
In a placebo controlled clinical trial in 2471 pregnant women who took Multivitamins and Minerals (Elevit Pre-conception) (one tablet daily for 1 to 6 months), the percent of subjects reporting adverse events was as follows: Constipation (1.8%), diarrhea (1.4%) and exanthema (0.08%). The percentages of subjects reporting these events in the placebo group were not statistically different.
A slight yellow discoloration of urine may be noticed. This effect is harmless and is due to the vitamin B2 contained in the preparation.
The product contains iron, which may lead to a black colouring of the stool. This effect is harmless and does not have any clinical relevance.
When used as recommended no specific interactions are expected. However, potential interactions for single ingredients are reported in the literature, thus patients receiving any other medication or those under medical care should consult a healthcare professional before taking this medicinal product.
Drug-Drug Interaction: The absorption of iron may be decreased by concurrent administration with antacids, gastric acid suppressive medications, fluoroquinolone, bisphosphonates, levodopa, levothyroxine, penicillamine, tetracycline antibiotics or trientine. If simultaneous use of one of these medications is necessary, administration should be separated by 2 to 3 hours. Products containing calcium, magnesium, iron, copper or zinc may interact with orally administered antacids, antibiotics (tetracyclines, fluoroquinolones), levodopa, biphosphonates, penicillamine, thyroxine, trientine, digitalis, antiviral agents and thiazide diuretics. If simultaneous use is necessary, administration of the two products should be separated by 2 hours.
Drug-Food Interactions: Since oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption, it is not recommended to take this product within two hours of eating foods containing high oxalic acid or phytic acid concentrations.
Store at temperatures not exceeding 30°C.
A11AA - Multivitamins with minerals ; Used as dietary supplements.
Elevit Pre-conception FC tab
30's (P21/film-coated tab, P630/box)
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